On December 2, 2024 Lixte Biotechnology Holdings, Inc. (the "Company") reported to have amended a Development Collaboration Agreement (the "Collaboration Agreement") with the Netherlands Cancer Institute, Amsterdam (NKI), one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, to identify the most promising drugs to be combined with LB-100, and potentially LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations (Filing, 8-K, Lixte Biotechnology, DEC 2, 2024, View Source [SID1234648720]).

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On November 29, 2024, the parties signed an amendment ("Amendment 3") to the Collaboration Agreement. This Amendment provides for a pause in the ongoing study activities and any payments thereunder until the initiation of a Phase 1b clinical trial combining LB-100 with a WEE1 inhibitor in metastatic colorectal cancer patients. The collaboration will resume upon dosing of the first patient in this clinical trial (the "Effective Date"), with the termination date revised to be one (1) year from the dosing date of the first patient.

Under Amendment 3, the parties will seek to study translational data derived from patient samples in clinical trials at NKI. Amendment 3 provides for a reduced annual budget of €100,000, invoiced quarterly, for one year from the Effective Date as compered to the initial budget of €250,000. The foregoing description of Amendment 3 does not purport to be complete and is subject to and qualified in its entirety by the full text of Amendment 3, a copy of which is filed hereto as Exhibit 10.1.

On December 2, 2024 Kura Oncology, Inc. (NASDAQ: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that it will be hosting a virtual investor event at 8:00 a.m. ET / 5:00 a.m. PT on Monday, December 9, 2024, to discuss the KOMET-007 combination trial of the Company’s oral and selective menin inhibitor, ziftomenib, following the presentation of updated clinical data at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego (Press release, Kura Oncology, DEC 2, 2024, View Source [SID1234648719]).

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The virtual event will feature members of the management team along with investigators from the KOMET-007 trial. The live call may be accessed by dialing (800) 715-9871 for domestic callers and (646) 307-1963 for international callers and entering the conference ID: 4326549. A live webcast will be available here and in the Investors section of Kura’s website, with an archived replay available shortly after the event.

On December 2, 2024 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported positive updated interim clinical data for its JANX007 clinical program. Janux will host a virtual event today at 4:30 PM ET (Press release, Janux Therapeutics, DEC 2, 2024, View Source [SID1234648718]).

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"These clinical data show substantial activity with JANX007 in 5L metastatic castration-resistant prostate cancer patients and provide compelling support for the doses we’ve selected for expansion trials directed at pre-PLUVICTO 2L and 3L patients," said David Campbell, Ph.D., President and CEO, Janux Therapeutics. "We look forward to rapidly advancing JANX007 into second and third-line therapy where a substantial unmet need remains and where we believe JANX007’s highly differentiated profile could allow for broad usage, if approved. This is an exciting day for Janux, but more importantly the prostate cancer patients we serve."

Updated interim, clinical data for PSMA-TRACTr JANX007 in mCRPC as of November 15, 2024

JANX007 is in a Phase 1a clinical trial in patients with advanced or metastatic prostate cancer (mCRPC). The patients enrolled in the trial were heavily pre-treated with a median of four prior lines of therapy. As of the November 15, 2024 data cutoff, 16 pre-PLUVICTO patients have been treated once-weekly at a target dose ranging from 2 mg to 9 mg in the Phase 1a clinical trial. High prostate-specific antigen (PSA) response rates and deep PSA declines were observed across all doses; 100% of patients achieved best PSA50 declines, 63% of patients achieved best PSA90 declines, and 31% of patients achieved best PSA99 declines. Durability of PSA declines at a target dose ≥ 2 mg were observed; 75% of patients maintained PSA50 declines at ≥ 12 weeks and 50% of patients maintained PSA90 declines at ≥ 12 weeks. Deep and durable PSA responses were observed irrespective of resistance driver aberration status, or prior treatments with a taxane or ARPi. In RECIST-evaluable patients, anti-tumor activity was observed with confirmed and unconfirmed partial responses in 50% (4/8) of patients.

JANX007 was well-tolerated with cytokine release syndrome (CRS) and CRS-related adverse events primarily limited to cycle 1 and grades 1 and 2. Similarly, treatment-related adverse events (TRAEs) not associated with CRS were primarily limited to cycle 1 and grades 1 and 2. The maximum tolerable dose for JANX007 has not yet been reached.

Based on these efficacy and safety results, two once-weekly step dose regimens have been identified for Phase 1b expansion trials directed at pre-PLUVICTO 2L and 3L patients. Janux anticipates providing another update on JANX007 in 2025.

Webcast Information

Janux will host a live webcast today at 4:30 PM ET. A live question and answer session will follow the formal presentation. To register for the event, please click here.

Participant Dial-In Details

USA & Canada: (800) 715-9871

International: 1 (646) 307-1963

Conference ID: 2229349

To access the live webcast, please visit the Investors section of the Company’s website. A replay of the webcast presentation will be available on the Company’s website at View Source for at least 30 days.

On December 2, 2024 Hepion Pharmaceuticals, Inc. (Nasdaq: HEPA) ("Hepion" or the "Company"), reported to have sent an open letter to shareholders urging them to vote for Hepion’s proposed merger with Pharma Two B Ltd. ("Pharma Two B") at the Company’s upcoming Special Meeting of Stockholders (the "Special Meeting") on December 12, 2024 (Press release, Hepion Pharmaceuticals, DEC 2, 2024, View Source [SID1234648717]).

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On December 2, 2024 Duke Street Bio Ltd, a precision medicine biotech developing next generation small molecule cancer therapies, reported that the first patient has been dosed in a Phase I trial evaluating the highly selective PARP1 inhibitor, DSB2455, in patients with solid tumours. DSB2455 is a potentially best-in-class, potent CNS penetrant PARP1 inhibitor with profound selectivity over the closely related enzyme PARP2 (Press release, Duke Street Bio, DEC 2, 2024, View Source [SID1234648716]).

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The Phase Ia/Ib trial is a multi-centre adaptively designed dose escalation study with expansion cohorts to assess the safety, tolerability, and activity of DSB2455 as monotherapy or in combination with anti-cancer agents in participants with advanced malignancies. First-generation non-selective PARP1/2 inhibitors have provided significant therapeutic benefit to patients whose tumours exhibit homologous repair (HR) deficiencies including BRCA mutations. However, their use has been associated with haematological toxicities that have restricted their application, particularly in combination with standard-of-care chemotherapy.

"Given that PARP2 is considered to drive haematoxicity, we believe that DSB2455 exhibits the optimal potency and selectivity profile to enhance efficacy and safety and may offer the potential to enable combination approaches with chemotherapy and radiotherapy" said Dónal Landers, M.D., Ph.D., Chief Medical Officer at Duke Street Bio Ltd.